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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / July 2026 / K254042

510(k) cleared

WatchPAT SW

Itamar Medical , Ltd. · Jul 31, 2026 · K254042

FDA cleared the WatchPAT SW from Itamar Medical , Ltd. on Jul 31, 2026 under K254042, a traditional 510(k). The device falls under product code MNR, Ventilatory Effort Recorder, regulated at 21 CFR 868.2375 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Dec 16, 2025. The decision came 227 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Itamar Medical , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254042?

K254042 is the FDA 510(k) for WatchPAT SW, submitted by Itamar Medical , Ltd.. FDA's decision date was Jul 31, 2026, under product code MNR (Ventilatory Effort Recorder).

Who makes the WatchPAT SW?

Itamar Medical , Ltd., based in Caesarea, is the applicant of record for K254042.

How long did the K254042 review take?

FDA received the submission on Dec 16, 2025 and issued its decision on Jul 31, 2026, 227 days later.

← All decisions in July 2026